A Study of the Safety and Efficacy of EBV Specific T-cell Lines

Official Title

A Phase I/II Open-label Study of the Safety and Efficacy of Epstein-Barr Virus Specific T-cell Lines for the Treatment of EBV Infection or EBV-related Lymphoproliferative Diseases

Summary:

This study evaluates the safety and efficacy of EBV-specific T-cell lines to treat patients
suffering from high EBV viral titers not responding to standard of care therapies and to
treat EBV-related lymphoma. The study will recruit 6 patients to receive autologous T cells
or a T cell line derived from the patient's allogeneic donor (in the case of stem cell
transplant recipients), and 6 patients to receive a T-cell line prepared from a matched or
partially matched related donor.

Malignancy staging for patients with lymphoma, per internationally-accepted guidelines for the different specific lymphomas

Epstein-Barr virus (EBV) is a member of the herpes virus family and infects up to 95% of
individuals over their lifetime. Most initial infections occur in childhood and after a brief
flu-like illness, the virus enters a phase of latency.
Patients who receive a bone marrow transplant or an organ transplant take medications drugs
that weaken their immune systems. In these contexts, the virus can "reactivate" and cause
very serious problems, such as lymphoma. For unknown reasons, people with a normal immune
system can also develop lymphoma due to EBV.
The purpose of this study is to test the safety and efficacy of immune cells (T lymphocytes)
that are specifically "taught" to recognize the virus-infected cells and to eliminate them.
This "education" occurs is done over during a 2 weeks period (approximately), in the research
laboratory. The cells are then transfused into the patient.